Colorectal Cancer, Esophageal Cancer, Grastic Cancer, Liver Cancer, Lung Cancer
Conditions
Keywords
multi-cancer early detection, MCED, cancer screening, circulating cell-free tumor DNA, methylation
Brief summary
This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.
Detailed description
Approximately 2527 participants will be enrolled and offered the multi-cancer early detection (MCED) test along with standard-of-care (SOC) cancer screenings and usual medical care. The investigational test is designed to detect five cancer types at a curable stage, which are lung cancer, colorectal cancer, liver cancer, gastric cancer and esophageal cancer. The test provides a binary result and predicts the signal origins if a cancer signal is detected. Those with "cancer signal detected" test results as well as those with warning signs of cancer during health check-up will undergo diagnostic procedures. The diagnostic work-up will be at the discretion of qualified oncologists, instead of being dictated by protocol. Both the safety and performance of MCED in the screening setting will be evaluated. The extent of diagnostic testing, including laboratory and imaging tests and procedures required to achieve diagnostic resolution, will be recorded and assessed. Additionally, patient-reported outcomes relating to the testing experience will also be collected at specified time points using the Electronic Clinical Outcome Assessment (eCOA) app. Participants will be actively followed for 1 year from the date of the blood draw.
Interventions
Blood collection for multi-cancer early detection（MCED）, followed by clinical diagnosis based on the results of MCED and standard-of-care screening
Sponsors
Shanghai Weihe Medical Laboratory Co., Ltd.
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* 40-74 years old * Able to provide a written informed consent and willing to comply with all parts of the protocol procedures
Exclusion criteria
* With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen * Have definite contraindications of cancer screening examination and diagnostic procedures * Unable to comply with the protocol procedures * Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date * Have received or are undergoing curative cancer treatment within three years prior to recruitment. Adjuvant endocrinotherapy for cancer is not an exclusion criterion. * Recipients of anti-tumor therapy within 30 days prior to screen * Pregnancy or lactating women * Recipients of organ transplant or prior bone marrow transplant or stem cell transplant * Recipients of blood transfusion within 7 days prior to screen * With autoimmune diseases * Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw * Unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of MCED in the intended use setting. | From enrollment to the Follow-up at 1 year | Descriptive statistics will be used to summarize the number of 5 pre-specified cancers diagnosed by MCED. |
| Safety of MCED in the intended use setting. | From enrollment to the Follow-up at 1 year | Descriptive statistics will be used to summarize the time to achieve diagnostic resolution following receipt of a positive MCED test and to assess the extent of testing pursued. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of MCED in the intended use setting. | From enrollment to the Follow-up at 1 year | Positive Predictive Value defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" test result. |
| Cancer signal origin accuracy of MCED. | From enrollment to the Follow-up at 1 year | Cancer signal origin accuracy defined as the proportion of participants with correct SCO predictions among those with positive test results who had a cancer diagnosis. |
| Clinical utility of MCED alongside SOC screening. | From enrollment to the Follow-up at 1 year | Descriptive statistics will be used to summarize the number and types of cancers diagnosed by MCED among participants who are ineligible for SOC screening. |
| Participant-reported psychological impact. | From enrollment to the Follow-up at 1 year | Changes in anxiety during study will be assessed using the short form of STAI (The state-trait anxiety inventory). Descriptive statistics for a total score will be used to measure feelings of anxiety. |
| Participant-reported health related quality of life (HRQoL) . | From enrollment to the Follow-up at 1 year | Changes in HRQoL during study will be assessed using the EQ-5D-5L. Descriptive statistics for an index value at various time points will be used to reflect how good or bad a health state is. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXianjun Yu
Fudan University
STUDY_DIRECTORXiaohui Wu
Shanghai Weihe Medical Laboratory Co., Ltd.
Outcome results
None listed